Mesalazine 1.5g per Sachet Gastro-Resistant Prolonged-Release Granules [PRESCRIPTION REQUIRED]

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For the treatment of acute episodes and the maintenance of remission of ulcerative colitis

Place of Origin

Germany

Product Usage

Adults and the elderly

For the treatment of acute episodes of ulcerative colitis:

Once daily, 1 sachet of Salofalk® 3g granules, 1-2 sachets of Salofalk® 1.5g granules, 3 sachets of Salofalk® 1 g granules or 3 sachets of Salofalk® 500mg granules (equivalent to 1.5-3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement.

It is also possible to take the prescribed daily dose in three divided doses (1 sachet of Salofalk® 500mg granules 3 times daily or 1 sachet of Salofalk??1 g granules 3 times daily) if this is more convenient to the patient.

For the maintenance of remission of ulcerative colitis:

The standard treatment is 0.5 g mesalazine 3 times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5 g mesalazine per day.

For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses, the dosing schedule can be adapted to 3.0 g mesalazine given as a single daily dose, preferably in the morning.

Paediatric population:

There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older:

Active disease: To be determined individually, starting with 30-50 mg/kg bw/day once daily preferably in the morning or in divided doses. Maximum dose: 75 mg/kg bw/day. The total dose should not exceed the maximum adult dose. Maintenance treatment: To be determined individually, starting with 15-30 mg/kg bw/day in divided doses. The total dose should not exceed the recommended adult dose.

It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg and the normal adult dose to those above 40 kg.

Ingredients

Aspartame (E 951), Carmellose sodium, Citric acid, Silica, colloidal anhydrous, Hypromellose, Magnesium stearate, Methacrylic acid-methyl methacrylate copolymer (1:1) (MW: approx. 135,000) (Eudragit L 100), Methylcellulose, Cellulose, microcrystalline, Polyacrylate dispersion 40 % (Eudragit NE 40 D containing 2 % Nonoxynol 100), Povidone K 25, Simeticone, Sorbic acid (Ph.Eur.), Talc, Titanium dioxide (E 171), Triethyl citrate, Vanilla custard flavouring (containing propylene glycol)

Warnings

Salofalk® granules are contraindicated in patients with:

- known hypersensitivity to salicylates or to any of the excipients

- severe impairment of hepatic or renal function.

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